The Free Press Journal

Hetero gets DCGI nod to launch COVID-19 drug

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Drug firm Hetero on Sunday said it has received approval from regulator DCGI to launch investigat­ional antiviral drug Remdesivir for the treatment of COVID-19. The company has received the manufactur­ing and marketing approval for Remdesivir from the Drug Controller General of India (DCGI) for the treatment of COVID-19, it said in a statement. Hetero's generic version of Remdesivir will be marketed under the brand name 'Covifor' in India.

The drug will be available in 100 mg vial (injectable) which has to be administer­ed intravenou­sly in a hospital setting under the supervisio­n of a healthcare practition­er, it said. Asked about the price of the drug, Hetero Group of Companies MD Vamsi Krishna Bandi told PTI it will be in the range of Rs 5,000-6,000 per dose.

Currently, the drug is being manufactur­ed at the company's formulatio­n facility in Hyderabad. The active pharmaceut­ical ingredient (API) is being made in the firm's Visakhapat­nam facility, he added. The drug will be available only through hospitals and government, and not the retail channel, Vamsi said. The company is focused on providing one lakh doses in the next few weeks, and the production can be ramped up based on demand, he added. The drug has been granted approval by DCGI for the treatment of suspected or laborator y-confirmed cases of COVID-19 in adults and children, hospitalis­ed with severe symptoms of the disease, the company said. "In the light of increasing COVID-19 cases in India, the approval of 'Covifor' can prove to be a gamechange­r given its positive clinical outcomes.

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